NCT00401024

Brief Summary

RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment. PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2008

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

November 16, 2006

Last Update Submit

June 26, 2018

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic oligodendrogliomaadult oligodendrogliomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcomarecurrent adult brain tumoradult brain stem gliomaadult mixed gliomaadult glioblastomaadult pilocytic astrocytomaadult diffuse astrocytomaadult anaplastic ependymomaadult ependymomaadult myxopapillary ependymomaadult subependymomaadult pineal gland astrocytomaadult subependymal giant cell astrocytoma

Outcome Measures

Primary Outcomes (1)

  • Tumor:plasma concentration ratio of imatinib mesylate

    2 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Drug: imatinib mesylateOther: pharmacological studyProcedure: conventional surgery

Interventions

imatinib mesylateDRUG
Treatment
pharmacological studyOTHER
Treatment
conventional surgeryPROCEDURE
Treatment

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma of 1 of the following subtypes: * Low-grade glioma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy * Scheduled to undergo surgical resection * Able to undergo maximal surgical resection of tumor mass PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Mini Mental Status Exam ≥ 15 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≥ 1.7 mg/dL * BUN ≤ 2 times upper limit of normal (ULN) * Transaminases ≤ 4 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment * No other medical illness that would preclude study treatment, including any of the following: * Serious infection * Uncontrolled hypertension * Unstable angina pectoris * Uncontrolled cardiac dysrhythmia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * At least 4 weeks since prior investigational drugs * No more than 1 prior chemotherapy regimen * No concurrent chemotherapy, biologic therapy, or radiotherapy * No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Holdhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19.

    PMID: 19768386RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsOligodendrogliomaAstrocytomaGlioblastomaGliosarcomaBrain NeoplasmsGliomaEpendymomaGlioma, Subependymal

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Stuart A. Grossman, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

October 12, 2006

Primary Completion

February 4, 2008

Study Completion

November 11, 2008

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(1)